公开(公告)号：US20150203532A1

公开(公告)日：2015-07-23

申请号：US14629356

申请日：2015-02-23

Applicant: Genzyme Corporation

Inventor： Rahul Godawat ,  Veena Warikoo ,  Rohan Patil ,  Konstantin Konstantinov ,  Venkat Kishore Ryakala ,  Mahsa Rohani

IPC: C07K1/22 ,  C12N9/40 ,  B01D15/42 ,  B01D15/36 ,  B01D15/38

CPC classification number: C07K1/16 ,  A61L2/081 ,  B01D15/1807 ,  B01D15/1864 ,  B01D15/20 ,  B01D15/363 ,  B01D15/3809 ,  B01D15/426 ,  C07K1/165 ,  C07K1/22 ,  C12N9/2465 ,  C12Y302/01022

Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.

公开(公告)号：US10087214B2

公开(公告)日：2018-10-02

申请号：US14598450

申请日：2015-01-16

Applicant: Genzyme Corporation

Inventor： Rahul Godawat ,  Veena Warikoo ,  Rohan Patil ,  Konstantin Konstantinov ,  Venkat Kishore Ryakala ,  Mahsa Rohani

IPC: A61L2/08 ,  B01D15/18 ,  B01D15/20 ,  B01D15/36 ,  B01D15/38 ,  B01D15/42 ,  C07K1/16 ,  C07K1/22 ,  C12N9/40

Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.

公开(公告)号：US20180354986A1

公开(公告)日：2018-12-13

申请号：US16107203

申请日：2018-08-21

Applicant: Genzyme Corporation

Inventor： Rahul Godawat ,  Veena Warikoo ,  Rohan Patil ,  Konstantin Konstantinov ,  Venkat Kishore Ryakala ,  Mahsa Rohani

IPC: C07K1/16 ,  B01D15/38 ,  B01D15/18 ,  C12N9/40 ,  C07K1/22 ,  B01D15/42 ,  A61L2/08 ,  B01D15/36 ,  B01D15/20

CPC classification number: C07K1/16 ,  A61L2/081 ,  B01D15/1807 ,  B01D15/1864 ,  B01D15/20 ,  B01D15/363 ,  B01D15/3809 ,  B01D15/426 ,  C07K1/165 ,  C07K1/22 ,  C12N9/2465 ,  C12Y302/01022

Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.

公开(公告)号：US20150203529A1

公开(公告)日：2015-07-23

申请号：US14598450

申请日：2015-01-16

Applicant: Genzyme Corporation

Inventor： Rahul Godawat ,  Veena Warikoo ,  Rohan Patil ,  Konstantin Konstantinov ,  Venkat Kishore Ryakala ,  Mahsa Rohani

IPC: C07K1/16

CPC classification number: C07K1/16 ,  A61L2/081 ,  B01D15/1807 ,  B01D15/1864 ,  B01D15/20 ,  B01D15/363 ,  B01D15/3809 ,  B01D15/426 ,  C07K1/165 ,  C07K1/22 ,  C12N9/2465 ,  C12Y302/01022

Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.

Abstract translation: 本文提供了使用γ-辐射色谱树脂进行色谱法的方法，其包括提供包含γ-辐射色谱树脂的色谱柱; 通过色谱柱进行第一次色谱循环，其中循环包括将色谱树脂暴露于变性缓冲液; 并通过柱进行至少一个附加的色谱循环。 还提供了整合的，封闭的或基本上封闭的，连续的制备重组蛋白质的方法，其包括使用至少一个色谱柱，包括γ-照射的色谱树脂，其中在每个过程中将γ-辐照色谱树脂暴露于变性缓冲液 在该过程中循环，并且在该过程中使用减少的生物负载缓冲液。

公开(公告)号：US11912739B2

公开(公告)日：2024-02-27

申请号：US16993654

申请日：2020-08-14

Applicant: Genzyme Corporation

Inventor： Rahul Godawat ,  Veena Warikoo ,  Rohan Patil ,  Konstantin Konstantinov ,  Venkat Kishore Ryakala ,  Mahsa Rohani

IPC: C07K1/16 ,  A61L2/08 ,  B01D15/18 ,  B01D15/20 ,  B01D15/36 ,  B01D15/38 ,  B01D15/42 ,  C07K1/22 ,  C12N9/40

CPC classification number: C07K1/16 ,  A61L2/081 ,  B01D15/1864 ,  B01D15/20 ,  B01D15/363 ,  B01D15/3809 ,  B01D15/426 ,  C07K1/165 ,  C07K1/22 ,  C12N9/2465 ,  B01D15/1807 ,  C12Y302/01022

Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.

公开(公告)号：US20200369718A1

公开(公告)日：2020-11-26

申请号：US16993654

申请日：2020-08-14

Applicant: Genzyme Corporation

Inventor： Rahul Godawat ,  Veena Warikoo ,  Rohan Patil ,  Konstantin Konstantinov ,  Venkat Kishore Ryakala ,  Mahsa Rohani

IPC: C07K1/16 ,  A61L2/08 ,  B01D15/18 ,  B01D15/20 ,  B01D15/36 ,  B01D15/38 ,  B01D15/42 ,  C07K1/22 ,  C12N9/40

Abstract: Provided herein are methods of performing chromatography with gamma-irradiated chromatography resin that include providing a chromatography column including a gamma-irradiated chromatography resin; performing a first cycle of chromatography through the column, where the cycle includes exposing the chromatography resin to a denaturing buffer; and performing at least one additional cycle of chromatography through the column. Also provided are integrated, closed or substantially closed, and continuous processes for manufacturing of a recombinant protein that include the use of at least one chromatography column including gamma-irradiated chromatography resin, where the gamma-irradiated chromatography resin is exposed to denaturing buffer during each cycle in the process, and reduced bioburden buffer is used in the process.